Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODEL LP-1000 VOLUME VENTILATOR (K952880)Aequitron Medical, Inc.1996-06-20
PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS (K954202)Medtronic Hemotec, Inc.1996-06-20
THYROID PEROXIDASE ANTIBODY ELISA (K960369)Immco Diagnostics, Inc.1996-06-20
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5 (K962107)Leonachi, Inc.1996-06-20
BARD GRAFT SIZER (K961134)C.R. Bard, Inc.1996-06-19
BREAST TREATMENT AID (K961170)S. and H. Engineering, Inc.1996-06-19
PLAYTEX SLIMFIT TAMPONS (K961870)Playtex Products, Inc.1996-06-19
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD (K955550)Intermedics, Inc.1996-06-19
EC-384OTL, VIDEO COLONSCOPE (K961563)Pentax Precision Instrument Corp.1996-06-19
SAM FACIAL IMPLANT (K961210)W. L. Gore & Associates, Inc.1996-06-19
DEPUY ADVANTAGE FIXATION SCREW SYSTEM (K961234)Depuy, Inc.1996-06-19
KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM (K961121)Siemens Medical Solutions USA, Inc.1996-06-19
MICRO ANASTOMOSIS CLAMP (K961100)R.S.P. Medical Management, Inc.1996-06-19
ARISTO ESOPHAGEAL STETHOSCOPE (K961060)Aristo Medical Products, Inc.1996-06-19
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING (K961323)Acme United Corp.1996-06-19
SAS SALMONELLA H Z4, Z24 ANTISERUM (K961960)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS (K961952)Sa Scientific, Inc.1996-06-18
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY (K960281)Intermedics, Inc.1996-06-18
SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM (K961963)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O POLY B ANTISERUM (K961967)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H Z4, Z32 ANTISERUM (K961957)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O FACTOR 6 ANTISERUM (K961951)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H G,M,Q ANTISERMU (K961956)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM (K961962)Sa Scientific, Inc.1996-06-18
DIGISCAN 2 PLUS (K955457)Siemens Medical Solutions USA, Inc.1996-06-18
SAS SALMONELLA O FACTOR 20 ANTISERUM (K961948)Sa Scientific, Inc.1996-06-18
CONMED VCARE RETRACTOR/ELEVATOR (K955446)Conmedcorp1996-06-18
TITANIUM HEALING CAPS (K960634)The Straumann Co.1996-06-18
SAS SALMONELLA H Z4 COMPLEX ANTISERUM (K961958)Sa Scientific, Inc.1996-06-18
HEARTPORT ENDOPULMONARY VENT (K961245)Heartport, Inc.1996-06-18
SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 (K961155)Douglas Medical Products Corp.1996-06-18
SAS SALMONELLA H F,G,T ANTISERUM (K961961)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H Z35 ANTISERUM (K961954)Sa Scientific, Inc.1996-06-18
DIA SCREEN 10 WAY REAGENT STRIPS (K961375)Genesis Labs, Inc.1996-06-18
SAS SALMONELA H Z24 ANTISERUM (K961953)Sa Scientific, Inc.1996-06-18
SHARPLAN LASERS, INC. RUBY LASER SYSTEM (K961279)Sharplan Lasers, Inc.1996-06-18
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (K961412)Bayer Corp.1996-06-18
SAS SALMONELLA O FACTOR 14 ANTISERUM (K961949)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM (K961966)Sa Scientific, Inc.1996-06-18
PLAYTEX TAMPONS #10296 (K961456)Playtime Products, Inc.1996-06-18
HEARTPORT ENDOSINUS CATHETER (K961270)Heartport, Inc.1996-06-18
CUSHMAN MANUFACTURING, INC. ULTRA 6.0. (K960802)Cushman Mfg., Inc.1996-06-18
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES (K961389)R. K. Medical L. L. C.1996-06-18
DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) (K961379)Depuy, Inc.1996-06-18
SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM (K961964)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM (K961950)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H Z42 ANTISERUM (K961955)Sa Scientific, Inc.1996-06-18
AMBULATORY (HOLTER) RECORDING SYSTEM (K950944)Biosensor Corp.1996-06-18
AMO PHACOFLEX II INTERSECTION SYSTEM (K961242)Allergan, Inc.1996-06-17
IMMULITE CMV IGG (K950672)Diagnostic Products Corp.1996-06-17
IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW (K960899)Imcor1996-06-17
OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER (K955342)Rashman Corp.1996-06-17
SERAQUEST TOXOPLASMA IGG (K960092)Quest Intl., Inc.1996-06-17
SYPHILIS IGG HUMAN SERUM CONTROLS (K960493)Pyramid Biological Corp.1996-06-17
SYSTEM, THERMAL REGULATING 74-DWJ (K960167)Augustine Medical, Inc.1996-06-17
VYGON PREMI-CATH - LONG TERM CATHETER (K954302)Vygon Corp.1996-06-17
AUTOMATIC VISUAL FIELD PLOTTER AP-125 (K961090)Kowa Optimed, Inc.1996-06-17
FULL FRAME ZOOM SYSTEM (K961193)Xre Corp.1996-06-17
COLISCREEN (K961191)Hardy Diagnostics1996-06-17
ACS FRT4 IMMUNOASSAY (K961510)Ciba Corning Diagnostics Corp.1996-06-17
STRESSWRITER EXERCISE TESTING SYSTEM (K961009)Hewlett-Packard Co.1996-06-17
CT PROSPEED CT/I (K961055)GE Medical Systems1996-06-17
0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER (K961208)Ptw-New York Corp.1996-06-17
VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES (K950838)Zymetx, Inc.1996-06-17
POWERED LOW AIR LOSS MATTRESS SYSTEM (K961159)Span-America Medical Systems, Inc.1996-06-14
AUTOMATED VITRECTOMY DEVICE (K961078)Promex, Inc.1996-06-14
COMPLEMENT CONTROL (K960874)Wako Chemicals USA, Inc.1996-06-14
CANDELA Q-SWITCHED ALEXANDRITE LASERS (K955662)Candela Laser Corp.1996-06-14
ELECSYS 2010 ANALYZER (K961481)Boehringer Mannheim Corp.1996-06-14
HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 (K960934)Hewlett-Packard Co.1996-06-14
MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE (K960531)Dako Corp.1996-06-14
FIRST CHOICE GLUCOSE URINE TEST STRIPS (K953661)Polymer Technology Intl.1996-06-14
VISART (K961092)Toshiba America Medical Systems, In.C1996-06-14
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) (K961354)Radiometer America, Inc.1996-06-14
KARL STORZ REMORGIDA FORCEPS (K962030)KARL STORZ Endoscopy-America, Inc.1996-06-14
FOUNDATION 9MM FORGED CEMENTED STEM (K961890)Encore Orthopedics, Inc.1996-06-14
ATI PLASMA PUMP (PP-04) (K961137)Apheresis Technologies, Inc.1996-06-14
MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE (K961435)Dako Corp.1996-06-14
5MM ENDOSCOPE (K960637)Origin Medsystems, Inc.1996-06-14
FIRST CHOICE KETONES URINE TEST STRIPS (K953662)Polymer Technology Intl.1996-06-14
MULTICHECK (K961355)Radiometer America, Inc.1996-06-14
SYNERGY PLUS (K960762)The Prometheus Group1996-06-13
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT (K933722)Horizon Diagnostics, Inc.1996-06-13
BREATH-TAKER BREATH-ALERT (K953411)Roxon - Universal Medical , Ltd.1996-06-13
NEUROVIEW SCISSORS (K961406)Neuro Navigational Corp.1996-06-13
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 (K961620)Roche Diagnostic Systems, Inc.1996-06-13
SUPPLE PERI-GUARD PERICARDIUM (K961810)Bio-Vascular, Inc.1996-06-13
THE IMS DPAP MASK, IMS MODEL NUMBER 82000 (K953697)Sleepnet Corporation1996-06-13
ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES (K961812)Conmedcorp1996-06-13
RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP (K960591)Chalgren Enterprises, Inc.1996-06-13
ELECSYS T4 ASSAY (K961490)Boehringer Mannheim Corp.1996-06-13
ALTA DOME AND PLUNGER (MEC HIP BOLT) (K961213)Howmedica Corp.1996-06-13
ADVANCED CARE HYDROPHILIC WOUND DRESSINGS (K961662)Mariner Biomedical, Inc.1996-06-13
PERI-GUARD PERICARDIUM (K961811)Bio-Vascular, Inc.1996-06-13
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (K955423)Fresenius USA, Inc.1996-06-13
CEDIA CORE TDM MULTI-CAL (K961659)Boehringer Mannheim Corp.1996-06-13
CEMENT AND BONE REMOVAL KIT (K961759)Maillefer Instruments S.A.1996-06-13
HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K955087)Bayer Corp.1996-06-13
PLAMP, PLAMP PLATE, PLAMP WITH HOOK (K942032)Hospital For Special Surgery1996-06-13
FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS (K953680)Polymer Technology Intl.1996-06-12
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Every clearance here is in the API, with alerts when new ones post.